Home GUDID 20304040024168 Henry Schein
Primary DI 20304040024168
Brand Henry Schein
Company HENRY SCHEIN, INC.
Model 5700122
Catalog number 5700122
Device description One Step+ Strep A Dipstick 50 Test
Published 2016-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name GTY ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GTY Antigens, All Groups, Streptococcus Spp. Microbiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20304040024168 Package GS1 12 In Commercial Distribution 10304040024161 Primary GS1 0 00304040024164 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20304040024168 20304040024168 10304040024161 10304040024161 00304040024164 00304040024164 304040024164 0304040024164
GMDN Terms# Term, Definition table Term Definition Beta-haemolytic Group A Streptococcus antigen IVD, kit, rapid ICT, clinical A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of antigens from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 No Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 012430880 Device count 50 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20612479281558 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 20612479281565 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 10612479281575 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 10612479281582 McKesson MCKESSON MEDICAL-SURGICAL INC. GTY 2026-02-06 00810107290132 Flowflex Plus Strep A Rapid Test Cassette Acon Laboratories, Inc. GTY 2025-12-01 00810107290156 Flowflex Plus Strep A Rapid Test Strip Acon Laboratories, Inc. GTY 2025-12-01 20810107290143 Flowflex Plus Strep A Rapid Test Cassette Acon Laboratories, Inc. GTY 2025-12-01 00810107290187 Flowflex Plus Strep A Rapid Test Strip Acon Laboratories, Inc. GTY 2025-12-01 10722066010751 Rapid Response BTNX Inc GTY 2025-05-29 00722066010754 Rapid Response BTNX Inc GTY 2025-05-29 30888277191888 MEDLINE MEDLINE INDUSTRIES, INC. GTY 2023-12-18 10722066006846 Rapid Response BTNX Inc GTY 2023-08-14 00722066006849 Rapid Response BTNX Inc GTY 2023-08-14 00816862023725 Preview WONDFO USA CO., LTD. GTY 2023-08-03 10816862023722 Preview WONDFO USA CO., LTD. GTY 2023-08-03 00695684755256 StrepAim GERMAINE LABORATORIES, INC GTY 2023-01-17 06974849369120 Group B Streptococcus Detection Kit(Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 06974849369137 Group B Streptococcus Detection Kit(Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 06974849369144 Group A Streptococcus Antigen Detection Kit (Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 06974849369151 Group A Streptococcus Antigen Detection Kit (Immunochromatography) Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. GTY 2022-12-06 20885380183628 CARDINAL HEALTH Cardinal Health 200, LLC GTY 2022-08-29 10885380183621 CARDINAL HEALTH Cardinal Health 200, LLC GTY 2022-08-29 00816862023589 Preview WONDFO USA CO., LTD. GTY 2021-08-20 10816862023586 Preview WONDFO USA CO., LTD. GTY 2021-08-20 05713106821756 S. pneumoniae reference strain 1 Ssi Diagnostica A/S GTY 2021-08-01 05713106821763 S. pneumoniae reference strain 2 Ssi Diagnostica A/S GTY 2021-08-01 05713106821770 S. pneumoniae reference strain 3 Ssi Diagnostica A/S GTY 2021-08-01 05713106821787 S. pneumoniae reference strain 4 Ssi Diagnostica A/S GTY 2021-08-01 05713106821794 S. pneumoniae reference strain 5 Ssi Diagnostica A/S GTY 2021-08-01 05713106821800 S. pneumoniae reference strain 6A Ssi Diagnostica A/S GTY 2021-08-01